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Effect of Aged Garlic Extract on Atherosclerosis (Garlic4)

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ClinicalTrials.gov Identifier: NCT01534910
Recruitment Status : Completed
First Posted : February 17, 2012
Results First Posted : April 3, 2015
Last Update Posted : April 20, 2017
Sponsor:
Collaborator:
Wakunaga Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Metabolic Syndrome
Interventions Drug: aged garlic extract
Drug: placebo
Enrollment 65
Recruitment Details all 65 participants were recruited
Pre-assignment Details  
Arm/Group Title Sugar Pill Aged Garlic Extract
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placebo

placebo: placebo

2400 mg of aged garlic extract

aged garlic extract: 2400 mg a day

Period Title: Overall Study
Started 33 32
Completed 29 28
Not Completed 4 4
Arm/Group Title Sugar Pill Aged Garlic Extract Total
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placebo

placebo: placebo patients were randomized to placebo

2400 mg of aged garlic extract

aged garlic extract: 2400 mg a day patients randomized to aged garlic extract

Total of all reporting groups
Overall Number of Baseline Participants 33 32 65
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 32 participants 65 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
33
 100.0%
32
 100.0%
65
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 33 participants 32 participants 65 participants
57  (7) 56  (8) 57  (7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 32 participants 65 participants
Female
9
  27.3%
8
  25.0%
17
  26.2%
Male
24
  72.7%
24
  75.0%
48
  73.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 33 participants 32 participants 65 participants
33 32 65
1.Primary Outcome
Title CT Angiography Plaque
Hide Description

we will measure low attenuation plaque at baseline (in volume) and then again at 1 year. we will assess if there is a reduction in low attenuation plaque volume (percent change from baseline), defined as [followup-baseline]/baseline x100%.

Baseline was time zero, followup CT scan was 1 year.

Time Frame baseline to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sugar Pill Aged Garlic Extract
Hide Arm/Group Description:

placebo

placebo: placebo patients were randomized to placebo No adverse events

2400 mg of aged garlic extract

aged garlic extract: 2400 mg a day patients randomized to aged garlic extract No adverse events

Overall Number of Participants Analyzed 28 27
Mean (Standard Deviation)
Unit of Measure: percent change of low attenuation plaque
0.17  (1.97) -1.53  (2.32)
2.Secondary Outcome
Title Coronary Calcium
Hide Description Agatston score is a semi-automated tool to calculate a score based on the extent of coronary artery calcification detected by an unenhanced low-dose CT scan. The calculation is based on the weighted density score given to the highest attenuation value (HU) multiplied by area of the calcification speck. The grading of coronary artery disease (based on total calcium score) is as follows: no evidence of CAD: 0 calcium score, minimal: 1-10, mild: 11-100, moderate: 101-400, and severe: >400
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
patients undergoing two calcium scores
Arm/Group Title Sugar Pill Aged Garlic Extract
Hide Arm/Group Description:

placebo

placebo: placebo

2400 mg of aged garlic extract

aged garlic extract: 2400 mg a day

Overall Number of Participants Analyzed 28 27
Mean (95% Confidence Interval)
Unit of Measure: agatston units
95
(74 to 116)
49
(20 to 78)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sugar Pill Aged Garlic Extract
Hide Arm/Group Description

placebo

placebo: placebo patients were randomized to placebo No adverse events

2400 mg of aged garlic extract

aged garlic extract: 2400 mg a day patients randomized to aged garlic extract No adverse events

All-Cause Mortality
Sugar Pill Aged Garlic Extract
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Sugar Pill Aged Garlic Extract
Affected / at Risk (%) Affected / at Risk (%)
Total   0/33 (0.00%)   0/32 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sugar Pill Aged Garlic Extract
Affected / at Risk (%) Affected / at Risk (%)
Total   0/33 (0.00%)   0/32 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Matthew Budoff
Organization: Los Angeles Biomedical Research Institute
Phone: 310-222-4107
EMail: mbudoff@labiomed.org
Layout table for additonal information
Responsible Party: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
ClinicalTrials.gov Identifier: NCT01534910     History of Changes
Other Study ID Numbers: 21567-01
First Submitted: February 14, 2012
First Posted: February 17, 2012
Results First Submitted: February 20, 2015
Results First Posted: April 3, 2015
Last Update Posted: April 20, 2017